Esophageal Squamous Cell Carcinoma (ESCC)Phase 3NCT07621601
A Study of HS-20093 in Patients With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC)
A Phase 3 study testing HS-20093 for Injection and Irinotecan; Paclitaxel; Docetaxel in people with Esophageal Squamous Cell Carcinoma (ESCC), run by Hansoh BioMedical R&D Company.
Trial summary
This is a multicenter, randomized, open-label, controlled phase III clinical study to evaluate the efficacy and safety of HS-20093- injection versus investigator's choice of chemotherapy in patients with locally advanced or metastatic esophageal squamous cell carcinoma after progress of first-line standard therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma (ESCC)
- What is being tested?
- HS-20093 for Injection and Irinotecan; Paclitaxel; Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 494 participants
- Where
- No sites listed yet
- Study dates
- 31 Jul 2026to 31 Dec 2032
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years at the time of informed consent form (ICF) signature, either sex.
- Be willing to participate in this clinical trial with understanding of study procedures, ability to provide written informed consent, and commitment to comply with all requirements specified in this clinical trial protocol.
- Patients with histologically or cytologically confirmed diagnosis of advanced recurrent or metastatic esophageal squamous cell carcinoma (ESCC), progressed after receiving first-line standard treatment.
- Presence of at least one target lesion according to RECIST v1.1.
- Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 to 1.
- Minimum life expectancy >12 weeks.
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- Adequate organ function.
- Absence of the following active infectious diseases: hepatitis B, hepatitis C, human immunodeficiency virus (HIV) infection, tuberculosis, or syphilis.
- Female patients with negative serum pregnancy test result within 7 days prior to first dose administration, or documentation of no pregnancy risk.
Who cannot join
- 1. Prior pathological diagnosis of esophageal adenocarcinoma, esophageal adenoid cystic carcinoma, esophageal mucoepidermoid carcinoma, esophageal undifferentiated carcinoma, esophageal neuroendocrine carcinoma, or esophageal mixed carcinoma 2. Prior or ongoing treatment with any of the following:
- Prior or current treatment targeting B7-H3;
- Prior or current treatment with topoisomerase I inhibitor agents, including antibody-drug conjugates with topoisomerase I inhibitor payloads, etc.; 3. Persistent adverse reactions caused by prior treatment. 4. Untreated brain metastases; uncontrolled brain metastases; presence of leptomeningeal or brainstem metastases; presence of spinal cord compression.
- 5. History of other primary malignancies. 6. Severe, uncontrolled, or active cardiovascular or cerebrovascular disease. 7. Severe or poorly controlled hypertension and diabetes mellitus. 8. Tumors have the risk of leading perforation/fistula, hemorrhage, or obstruction.
- 9. Known or suspected interstitial pneumonitis, immune-mediated pneumonitis, or radiation pneumonitis.
- 10. Known to have allergic reactions or contraindications to the investigational medicinal product.
About this study
Official title: A Multicenter, Randomized, Open-Label, Controlled Phase III Clinical Study Evaluating the Efficacy and Safety of HS-20093- Injection Versus Investigator's Choice of Chemotherapy in Patients With Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma After Progress of First-Line Standard Therapy
This is a multicenter, randomized, open-label, controlled phase III clinical study to evaluate the efficacy and safety of HS-20093- injection versus investigator's choice of chemotherapy in patients with locally advanced or metastatic esophageal squamous cell carcinoma after progress of first-line standard therapy.
Read the detailed description
This is a multicenter, randomized, open-label, controlled phase III clinical study to evaluate the efficacy and safety of HS-20093- injection versus investigator's choice of chemotherapy in patients with locally advanced or metastatic esophageal squamous cell carcinoma after progress of first-line standard therapy.
Eligible participants will be randomly assigned in a 1:1 ratio to the experimental arm (HS-20093) or the control arm (investigator's choice of monochemotherapy, including irinotecan, paclitaxel, or docetaxel). Both experimental arm and control arm will receive a treatment cycle of 21 days until disease progression or other treatment discontinuation criteria are met; Efficacy and safety will be analyzed and evaluated in both arms following the protocol-specified follow-up procedure.
- Being tested
- HS-20093 for Injection, Irinotecan; Paclitaxel; Docetaxel
- Keywords
- ESCC, HS-20093, advanced, metastatic
- Medical subject headings
- Esophageal Squamous Cell Carcinoma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-20093 for InjectionDrug
Also called Risvutatug Rezetecan for injection, GSK5764227
The patient will receive treatment with HS-20093.
Irinotecan; Paclitaxel; DocetaxelDrug
The patient will receive treatment with Irinotecan or Paclitaxel or Docetaxel
| Study group | Role | What they receive |
|---|---|---|
| HS-20093 for injection | Experimental | Not described Receives: Drug: HS-20093 for Injection |
| Investigator's choice of monochemotherapy | Active comparator | Investigator should choose one of the monochemotherapy (irinotecan, paclitaxel, or docetaxel) Receives: Drug: Irinotecan; Paclitaxel; Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Overall Survival is defined as the time from the date of randomization to the date of participant's death due to any cause
Measured: Approximately 4 years after the first patient with first dose
Secondary outcomes (6)
Progression-free survival (PFS) assessed by investigator
PFS assessed by investigator per RECIST v1.1
Measured: Approximately 3 years after the first patient with first dose
Objective response rate (ORR)
ORR assessed by investigator per RECIST v1.1
Measured: Approximately 2 years after the first patient with first dose
Disease control rate (DCR)
DCR assessed by investigator per RECIST v1.1
Measured: Approximately 2 years after the first patient with first dose
Duration of response (DoR)
DoR assessed by investigator per RECIST v1.1
Measured: Approximately 3 years after the first patient with first dose
Incidence and severity of AEs
Measured: From the first dose until 90 days after the last dose
Incidence and severity of SAEs
Measured: From the first dose until 90 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start31 Jul 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell Carcinoma (ESCC)Studies of the same condition, open and under way.
- More trials run by Hansoh BioMedical R&D CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 494 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hansoh BioMedical R&D Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07621601
- Sponsor's protocol ID
- HS-20093-310
- Status last verified
- May 2026
- First submitted
- 26 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open-Label, Controlled Phase III Clinical Study Evaluating the Efficacy and Safety of HS-20093- Injection Versus Investigator's Choice of Chemotherapy in Patients With Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma After Progress of First-Line Standard Therapy
- ClinicalTrials.gov ID
- NCT07621601
- Acronym / sponsor ID
- HS-20093-310
- Keywords
- ESCC, HS-20093, advanced, metastatic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 494 participants (estimated)
- Lead sponsor
- Hansoh BioMedical R&D CompanyIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, randomized, open-label, controlled phase III clinical study to evaluate the efficacy and safety of HS-20093- injection versus investigator's choice of chemotherapy in patients with locally advanced or metastatic esophageal squamous cell carcinoma after progress of first-line standard therapy.
Detailed description
This is a multicenter, randomized, open-label, controlled phase III clinical study to evaluate the efficacy and safety of HS-20093- injection versus investigator's choice of chemotherapy in patients with locally advanced or metastatic esophageal squamous cell carcinoma after progress of first-line standard therapy.
Eligible participants will be randomly assigned in a 1:1 ratio to the experimental arm (HS-20093) or the control arm (investigator's choice of monochemotherapy, including irinotecan, paclitaxel, or docetaxel). Both experimental arm and control arm will receive a treatment cycle of 21 days until disease progression or other treatment discontinuation criteria are met; Efficacy and safety will be analyzed and evaluated in both arms following the protocol-specified follow-up procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HS-20093 for injection | Experimental | Drug: HS-20093 for Injection |
| Investigator's choice of monochemotherapy | Active comparator | Drug: Irinotecan; Paclitaxel; DocetaxelInvestigator should choose one of the monochemotherapy (irinotecan, paclitaxel, or docetaxel) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥18 years at the time of informed consent form (ICF) signature, either sex.
- Be willing to participate in this clinical trial with understanding of study procedures, ability to provide written informed consent, and commitment to comply with all requirements specified in this clinical trial protocol.
- Patients with histologically or cytologically confirmed diagnosis of advanced recurrent or metastatic esophageal squamous cell carcinoma (ESCC), progressed after receiving first-line standard treatment.
- Presence of at least one target lesion according to RECIST v1.1.
- Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 to 1.
Key exclusion criteria (6 listed)
- 1. Prior pathological diagnosis of esophageal adenocarcinoma, esophageal adenoid cystic carcinoma, esophageal mucoepidermoid carcinoma, esophageal undifferentiated carcinoma, esophageal neuroendocrine carcinoma, or esophageal mixed carcinoma 2. Prior or ongoing treatment with any of the following:
- 5. History of other primary malignancies. 6. Severe, uncontrolled, or active cardiovascular or cerebrovascular disease. 7. Severe or poorly controlled hypertension and diabetes mellitus. 8. Tumors have the risk of leading perforation/fistula, hemorrhage, or obstruction.
- 9. Known or suspected interstitial pneumonitis, immune-mediated pneumonitis, or radiation pneumonitis.
- 10. Known to have allergic reactions or contraindications to the investigational medicinal product.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HS-20093 for InjectionAlso: Risvutatug Rezetecan for injection, GSK5764227The patient will receive treatment with HS-20093. | Drug | HS-20093 for injection |
| Irinotecan; Paclitaxel; DocetaxelThe patient will receive treatment with Irinotecan or Paclitaxel or Docetaxel | Drug | Investigator's choice of monochemotherapy |
Primary outcome
Overall survival (OS)
Time frame: Approximately 4 years after the first patient with first dose
Overall Survival is defined as the time from the date of randomization to the date of participant's death due to any cause
6 secondary outcomes
Progression-free survival (PFS) assessed by investigator
Time frame: Approximately 3 years after the first patient with first dose
Objective response rate (ORR)
Time frame: Approximately 2 years after the first patient with first dose
Disease control rate (DCR)
Time frame: Approximately 2 years after the first patient with first dose
Duration of response (DoR)
Time frame: Approximately 3 years after the first patient with first dose
Incidence and severity of AEs
Time frame: From the first dose until 90 days after the last dose
Incidence and severity of SAEs
Time frame: From the first dose until 90 days after the last dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HS-20093 for Injection and Irinotecan; Paclitaxel; Docetaxel in people with Esophageal Squamous Cell Carcinoma (ESCC), run by Hansoh BioMedical R&D Company.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: Approximately 4 years after the first patient with first dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.